MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. ASAHI SIONBLUE GUIDEWIRE; PTCA GUIDEWIRE

Catalog Number AHW14R004S

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212); Stretched (1601)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Chest Pain (1776); Device Embedded In Tissue or Plaque (3165)

Event Date 01/02/2015

Event Type  Injury  

Event Description

Reportedly, in the procedure for 95% occluded, heavily calcified, tortuous lesion at prox-distal rca, subject guidewire was advanced but other company's guidewire was advanced as buddy-wire technique and a stent was implanted over this latter guidewire, subject guidewire was jailed.Jailed subject guidewire was pulled back for the process of 2nd stenting, but the tip of the wire unravelled and a short segment of wire was left in the artery.2nd sent was deployed in order to cover the broken segment of the guidewire, but supposedly a small segment of the wire might be protruded into the lumen of the vessel and it was not feasible to pass a balloon to post dilate.The patient was advised to stay in hospital an extra day, but self discharged the following day as he felt well.The following morning patient developed chest pain and came to hospital with heart block, hypotension and inferior st elevation.Cabg and implantation of icd was performed, patient had to stay in the hospital for about a month.Finally the patient was discharged.

Manufacturer Narrative

Guidewire was not available for manufacturer's investigation.Lot history review could not be conducted since no lot information was available, however there is no indication of a product deficiency, since all the shipped products are inspected in the production process for meeting the product specifications and release criteria.With the obtained information, it is inferred that the guidewire distal end might be trapped by the deployed stent, where removal manipulation was applied, resulting the breakage of the core wire of the guide wire due to the force exceeding the product design limit and elongation of coil wire.Coil wire might be cut off along with further removal of the guidewire.

• Brand Name: ASAHI SIONBLUE GUIDEWIRE
• Type of Device: PTCA GUIDEWIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489- 0071; JA 489-0071
• Manufacturer Contact: eiichi kubo ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071 ; 1485551
• MDR Report Key: 4691930
• MDR Text Key: 5713569
• Report Number: 3003775027-2015-00032
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: IC
• PMA/PMN Number: K122468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AHW14R004S
• Other Device ID Number: 454732708622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 04/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 73 YR
• Patient Weight: 100